adult patients with type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10012601 Term: Diabetes mellitus
Conditions
Interventions
Product Name: 2 x 10 mcg CYT013-IL1bQb + Alhydrogel
Product Code: CYT013-IL1bQb
Pharmaceutical Form: Solution for injection
Current Sponsor code: CYT013-IL1bQb
Concentration unit: µg/ml microgram(s)/
Sponsors
Cytos Biotechnology AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Diagnosis of type 2 diabetes mellitus, according to the American Diabetes Association diagnostic criteria, = 3 months at time of randomization • Stage I: HbA1c in the range of 6.5 - 9.5% (inclusive) at screening/ Stage II: HbA1c in the range of 7.0 – 9.5 % (inclusive) • = 18 30 U/L) or surgically sterilized (documentation required). • BMI = 23 kg/m2 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Positive for GAD65 or IA-2 auto-antibodies • Symptoms of hyperglycemia (i.e. polyuria and polydypsia) in the opinion of the investigator • History of significant weight gain or loss (+/- 5%) during the 4 weeks before randomization • Fasting C-peptide level 95 mmHg and/or systolic >170 mmHg • Evidence of active infection, CRP > 30 mg/L, history of recent infection or of chronic infection requiring treatment with anti-infectives, hospitalization or therapy with antibiotics within 4 weeks prior to randomization • History of tuberculosis or tuberculosis exposure; positive test result in a tuberculosis- specific Interferon gamma release assay at screening • Active leg or foot ulcer • Persistent asthma or COPD treated with inhalative corticosteroids • Known proliferative retinopathy or macular edema • White blood cell (leucocytes) count at screening 107 mcmol/L for female and >115 mcmol/L for male • Estimated glomerular filtration rate (eGFR) at screening 50 mg/g creatinine • Malignancy (present or in anamnesis), with the following exceptions: non-invasive basal cell carcinoma (basaliom) of the skin in anamnesis or carcinoma in situ of cervix uteri in anamnesis • Current systemic anti-inflammatory therapy other than aspirin = 100 mg/day or immunosuppressive treatment, in particular oral corticosteroids • Receipt of any biologic or immunosuppressive therapy (experimental or commercial), including anakinra (Kineret®), IL-1 beta blocking monoclonal antibodies, soluble IL-1 receptor or any tumor necrosis factor (TNF) blocking agents (eg, etanercept and infliximab), within 3 months of randomization • Antidiabetic medication other than metformin, sulfonylurea • Planned prophylactic immunization with live vaccines 3 months prior to screening or during the study (including Follow Up) •Planned active immunization with other (than live vaccines) prophylactic vaccines within 2 weeks before or 2 weeks after any application of study medication • Use of an investigational medicinal product within 30 days before enrolment, or planned use during the whole study period • Known autoimmune disease • Severe allergy • Pregnancy or breastfeeding • Women of childbearing age that are not surgically sterilized • Patients with a history or current positive test for HIV infection, AIDS, or other immunosuppressive disorders; hepatitis B or C • Presence of suspicious lymphadenopathy or splenomegaly on physical examination • Drug or alcohol abuse within the past 2 years before screening • Presence or history of relevant cardiovascular disease (myocardial infarction <6 months before r
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: na;Primary end point(s): Primary outcome measures are safety, tolerability and immunogenicity of CYT013-Il1bQb throughout the study. ;Main Objective: • To evaluate safety and tolerability of up to 4 different dose regimens of CYT013-IL1bQb in patients with type 2 diabetes mellitus • To assess pharmacodynamic effects and dose-response (immunogenicity and biomarkers) of up to 4 dose regimens of CYT013-IL1bQb in patients with type 2 diabetes mellitus • To explore preliminary clinical efficacy (effects on fasting plasma glucose, HbA1c) of CYT013-IL1bQb in patients with type 2 diabetes mellitus | — |
Countries
Germany
Outcome results
None listed